Cypress Medical recalls Acceava Respiratory Strep A devices due to shipping to customers without proper licenses. All units with catalog number 4580295008 are affected.
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Cypress Medical is recalling Acceava Respiratory Strep A devices because they were shipped to customers who don't have the required license to purchase them. This means the devices may not be legally used by some people, but there's no immediate safety risk to users.
The devices were shipped to customers who don't have the required license to purchase them due to a classification error in the company's inventory system. This means the devices might not be legally used by some people, but there's no risk of injury or harm to users.
Anyone who purchased the Acceava Respiratory Strep A device with catalog number 4580295008. People without the proper license to use these devices are most at risk of legal issues.
Check for the catalog number 4580295008 on the device. All lots of this product are affected, so any unit with this number should be considered part of the recall.
Verify if you have the required license to use this device. If not, contact Cypress Medical for guidance.
No, the device itself is not dangerous. The recall is due to a licensing issue, not a safety hazard.
No, you don't need to stop using it. The recall is about legal compliance, not safety.
Look for the catalog number 4580295008 on the device. All lots of this product are affected.
We’ve drafted a message you can send Cypress Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3185-2024 — Cypress Medical Cypress Medical Hello, I own a Cypress Medical that is covered by recall Z-3185-2024 from Cypress Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.